EP4056221A1 - Tubular device and method for selectively stiffening a tubular device - Google Patents

Abstract

The invention relates to a hose device (101), in particular a sluice device for insertion into a body duct, which can be reversibly stiffened by the concentric arrangement of an inner (1) and outer hose (4) and a stiffening layer (3) by applying pressure by applying pressure to the stiffening layer exerts on the outer hose and thus generates strong friction.

Description

The invention is directed to a tube assembly and a method for selectively stiffening a tube assembly.

In minimally invasive surgical procedures, such as the treatment of aneurysms by placing stents, dilating, lysing and embolizing, tube devices are used that can be inserted into the body via the vessels.

In many cases, the catheters, which are often inserted through the groin artery, must be able to travel long distances in the patient's body and meander along the blood vessels.

In addition, an interior space within the catheter for the introduction of tools and/or a guide wire and/or operative treatment elements such as stents, coils or the like must be possible for the treatment.

With these medical treatments, it is particularly important to be able to work as precisely and minimally invasively as possible, since the health of those being treated can be affected.

Since the tube device, eg a catheter, must be elastically deformable in order to be able to adapt to the vascular coils, to be able to be controlled and inserted, it can slip off or be deflected very easily. On the one hand, this is very dangerous because it makes it difficult to work precisely and the treatment can be prolonged. On the other hand, the flexible catheter increases the risk of harm to the patient suffer or even die. For example, an aneurysm, or calcium deposits in the vessels, can become detached through unfavorable slippage and cause serious damage. It is often necessary to switch to a different catheter, so that the material consumption is very high and so are the costs.

It is therefore the object of the present invention to overcome these disadvantages of the prior art and to present a device with which minimally invasive surgical interventions are associated with the lowest possible risk, can be carried out quickly and the costs can be kept low.

The object is solved by a hose device according to the independent claims of the invention.

A tube device, in particular a sluice device, for insertion into a body duct, comprises a stiffening section with an inner tube, as well as a stiffening layer and an outer tube. The stiffening layer is arranged concentrically outside the inner tube and the outer tube is arranged concentrically outside the stiffening layer. The inner tube and the outer tube are designed to be radially stiff and the stiffening layer is designed to be radially movable. A pressure can be built up between the inner tube and the stiffening layer in such a way that the stiffening layer can be pressed from the inside against the outer tube and thus stiffens the stiffening section under pressure.

The hose device thus has the advantage that it can be reversibly stiffened by pressure during use. The preferred pressure is essentially in a range of 3-40 bar, in particular essentially 16 bar. but other pressure ranges are also conceivable as long as stiffening is guaranteed.

Radially rigid within the meaning of the invention means that the radially rigid layer can only be minimally expanded by pressure in the radial direction and thus pressure can be applied at all. Radially movable means that the layer is not radially rigid. Radially stiff does not preclude the layer from being flexible in other directions.

The pressure may preferably be checked and released applied by an external device, which may include further protective measures such as shutting off in the event of a pressure drop through a leak, or applied manually.

At this point it should be noted that the pressure difference to the human body must be taken into account. The hose device is therefore designed in such a way that a high pressure can be supplied and discharged. A pressure above atmospheric pressure is preferably used and no vacuum or subatmospheric pressure. This has the advantage that the pressure difference is much higher, as the negative pressure is limited to a maximum of 1 bar.

The formation of a stiffener makes it easier to fix the tube device at the desired location and allows a more precise intervention, which increases the safety of the patient, can be carried out more practicably and ensures faster work.

In the stiffened state, the pressure can also be reduced again and the stiffening can be reversed.

The area of the tube device designed to be stiffenable can also vary in length, since the stiffening layer does not have to be designed over the entire length of the tube device. Accordingly, certain areas of the hose device can be designed to be stiffenable. The stiffening section of the hose device can comprise the complete hose device or only a partial section. If only a section of the tube device is formed by the stiffening section, the rest of the tube device cannot be stiffened.

In the innermost part of the tube device there is an interior space which is surrounded by the inner tube, so that a lumen is created in the interior space which, when used properly, is not reduced by kinks or pressure on the tube device. This lumen has an opening at each end of the tube device.

To this end, it is important that the inner and outer tubes are designed to be radially stiff. This radial rigidity means that there are no or only small expansions and constrictions of the inner and outer hose. This ensures that there are no kinks in the hoses that would severely narrow the interior space and restrict the introduction and use of the device in the hose device.

Nevertheless, a high degree of flexibility and bendability of the tube device is possible, so that the tube device can complete turns along the vessels and branches of the vessels.

The radial mobility of the stiffening layer, on the other hand, is important so that the stiffening section stiffens under pressure can be, as this is only possible by form fit and / or force fit if the stiffening layer can be pressed from the inside against the outer tube by the pressure built up.

In the hose device, an expandable, in particular elastic and/or unfoldable, pressure hose can preferably be arranged between the inner hose and the stiffening layer.

The pressure hose can be subjected to pressure and thus press the stiffening layer against the outer hose and stiffen the stiffening section of the hose device. This arrangement offers the advantage that the pressure hose also represents a safety mechanism.

It should be noted that this arrangement is advantageous for potential leaks in the hose. Patient safety would be assured despite a leak, as pressure is built up between the inner tube and the stiffening layer in the pressure tube. A double leak would therefore have to occur for the pressure to escape via the outer hose.

In addition, pressure can thus be exerted on the stiffening layer without the stiffening layer having to have a dense layer. A stiffening layer of spirally arranged elements is also conceivable, or a stiffening layer which forms a closure with a complementary inner surface of the outer tube for stiffening the tube device. However, the stiffening layer is preferably not manufactured monolithically. This preferred design of the tube device enables a more flexible design of the stiffening layer, since it has a non-closed, e.g. perforated, corrugated, spiral, mesh, interlaced or net structure, construction or surface. This can have an advantageous effect on the stiffening of the stiffening section, since the stiffening section can thus also be stiffened more easily during severe bending.
The pressure hose can expand when subjected to pressure and preferably comprises elastically deformable material, and/or a foldable material, for example a plastic.
Nylon, polyethylene terephthalate and/or polyether block amide are particularly suitable for an expandable and collapsible pressure hose.

In a particularly advantageous manner, the pressure hose comprises stretchable elastomers or other thermoplastic material, such as silicone and/or thermoplastic elastomers and/or foldable plastics. These substances have a high level of biocompatibility, are non-toxic, are inexpensive and preferably have very good elastic deformability.

A pressure hose is particularly advantageous which can be in a folded state without the action of additional pressure and in an unfolded state when pressure is applied. A pressure hose that can be folded up in this way ensures a fixed maximum and minimum size when the correct pressures are applied, and stiffening with maximized tightness can be guaranteed.

The stiffening layer can comprise at least two stabilization elements, with the orientation of the stabilization elements being at least one partial vector in the longitudinal direction of the hose device has and the stabilizing elements are preferably mutually displaceable.

In the non-stiffened state, the individual stabilizing elements can be movable relative to one another, in particular displaceable. The stabilizing elements are preferably not very elastic in tension and preferably also not very elastic in compression in the longitudinal direction.

The stabilizing elements of the stiffening layer are preferably formed to a greater extent along the longitudinal direction, so that the angle of the stabilizing elements between the longitudinal axis of the hose device and the stabilizing element is in a range between -45° and 45°, in particular between -30° and 30°. It is also possible to provide different orientations, ie two or more different angles to the longitudinal axis of the stabilizing elements with respect to the longitudinal axis. This has the advantage that the bendability is only slightly restricted, but the form fit during the stiffening in the longitudinal direction between the stiffening layer and the outer hose and preferably the pressure hose is reinforced.

The stabilizing elements are preferably shaped in such a way that they have a high level of friction with the outer tube due to high pressure in the direction of the outer tube and can lead to a stiffening of the tube device.

The stiffening layer and/or stabilizing elements preferably include metals and/or plastics. Stainless steel or polyamide, for example, are particularly suitable.

This cohesion between the individual stabilizing elements of the stiffening layer can be formed by mechanical adhesion, such as form-fitting clamping in depressions, and/or by specific adhesion.

In this context, the use of stabilizing elements on the outer tube or the use of additional stabilizing elements on the inside of the outer tube would also be conceivable, which could contribute to stiffening, for example through a positive fit.

The stabilizing elements of the tube device are preferably made of metal and/or plastic.
In particular, a multiplicity of stabilizing elements are preferably interwoven to form a braid.

Metals and plastics have very good elastic properties and are usually inexpensive. Good elasticity is also very important for the material, so that when the force is removed, the pressure can return to its original shape. This ensures that the hose device can be stiffened, but can also become elastically deformable again when the pressure is reduced. It is also advantageous if there is no strong elastic hysteresis in the material, i.e. a deformation can remain after the deflecting forces have been removed. Elastic hysteresis is counteracted by the structure of a braid, use of an elastic material and/or non-plastic deformation.

The elasticity of the stiffening layer can also be achieved by the type of stiffening layer instead of or in addition to the material elasticity. A relatively loose braid can achieve a certain elastic radial deformation by applying pressure, even if the material of the mesh itself is not or hardly elastic.

The use of stabilizing elements made of metal and/or plastic also enables cost-effective production. A braid can be machined very quickly, thus reducing the cost of the invention.

A particularly advantageous design results for the rather acute angles described above, in combination with a braid.

Nevertheless, other manufacturing options for producing an advantageous structure for the stabilizing elements, such as laser cutting, would also be conceivable.

The inner hose and the outer hose of the hose device are preferably designed to be pressure-tight and, in particular, are made of a plastic and/or metal.

The inner and outer tubes preferably both have a wall thickness in a range from 0.01 to 0.8 mm, in particular 0.2 mm, and can be made of materials such as stainless steel, platinum, iridium, barium, tungsten and/or plastic, in particular thermoplastics such as silicones, polyetheretherketone, fluoropolymers, polyvinyl chloride and polyurethane.

When choosing the material, care must be taken to ensure that the mechanical properties, in terms of flexibility, the surface structure, in terms of thrombogenicity, and the chemistry of the surface, in terms of coatability and charging, are advantageous. These beneficial properties have the materials mentioned above and are therefore suitable for use in the hose device.

In addition, the inner and outer hoses are preferably reinforced so that the hoses do not twist axially, the cross section is not enlarged and/or compressed to such an extent under pressure and the hose has a higher pressure resistance. For the reinforcement, the inner and outer hose can be stabilized with spirals, meshes, a wire or a braid with a transverse orientation. The armor structure is preferably optimized for a ratio of resistance to radial expansion and longitudinal expansion, for example by adjusting the thickness of the armor and the angle to the hose device.

The choice of these materials and an advantageous reinforcement for the inner hose and outer hose ensure that the hose device is elastically deformable but cannot be compressed when used properly. This always ensures that the interior space or the lumens are free, but that the tube device can elastically adapt to the course of the vessels. In the longitudinal direction, the outer and inner tubes should also preferably not be elastically deformable, or only slightly so.

The hose device preferably comprises a fluid coupling, through which a fluid can be introduced into the area between the inner hose and the stiffening layer, in particular into the pressure hose.

The fluid coupling of the hose device is advantageous since fluid can thus be introduced into the area between the inner hose and the stiffening layer. The fluid can Be liquid, such as water, salt water or a gas. The introduction of a fluid between the inner hose and the stiffening layer, in particular in the pressure hose, thus facilitates the stiffening of the hose device. However, preference is given to using a liquid, since this is less dangerous to people if it escapes than a gas, in particular air.

The tube device can preferably at least partially comprise a material that is visible in X-rays, in particular metal.

In the case of minimally invasive operations with tube devices, the position of the tube device and in particular of the inserted end of the tube device cannot be seen with the naked eye. Accordingly, an imaging method must preferably be used to visualize the inserted tubing device. An X-ray method, such as fluoroscopy, is preferably used so that real-time imaging of the inserted tube device can be ensured.

Since the attenuation of X-rays is given by the mass attenuation coefficient, a material with elements with a high atomic number should be chosen.

Because plastic is often primarily composed of carbon compounds, which are poor X-ray absorbers, the tubing assembly should instead contain visible material such as modified plastics or metals. Even small amounts of iron, for example, can ensure the visibility of the hose device.

A front area of the hose device can preferably be designed conically so that no step occurs.

According to the invention, the front area of the hose device is the part that is introduced first into the patient's vessel.

The front area of the hose device should be as conical as possible, since this offers the advantage that the risk of injury when using the hose device is minimized. When inserting the tubing assembly into a patient, a tapered front portion of the tubing assembly causes less or no injury and pain. In addition, the required force is lower and the application is easier to carry out. A conical front area is also advantageous when guiding along the vessels of a person, since on the one hand the curves in the vessels are easier to follow if the front area is narrower and is therefore more easily elastically deformable. On the other hand, a conical front area minimizes damage to vessels and the potential loosening of deposits or clots.

A hydrophilic or hydrophobic coating can be arranged on the outside of the outer tube of the tube device. In addition, a coating in the inner hose with polytetrafluoroethylene is particularly advantageous.

The coating of the outer tube can, among other things, improve the sliding behavior and minimize friction. On the other hand, biocompatibility must be guaranteed or the risk of infection must be kept low, and haemocompatibility, antithrombogenicity or low particle release must be optimized becomes. Polymer coatings are particularly suitable for this purpose.

In the coating process, the surface is preferably activated beforehand in order to be able to receive coatings. This can be done, for example, by plasma activation, in which an electron plasma causes open binding sites to form on the surface, which are occupied by polar hydroxy groups. This creates a hydrophilic surface and the polymer coating can adhere better.

The surface to be coated can be made hydrophilic or hydrophobic, for example by plasma polymerisation in a vacuum by supplying gas with precursor monomers which are deposited on the surface, depending on the precursor monomers. Other coating methods such as dip coating, spray coating, reel-to-reel coating are also conceivable.

In a final step, the molecules of the coating can be crosslinked even more by applying thermal energy or UV radiation.

Polytetrafluoroethylene is suitable as a hydrophobic coating for the outer tube, since the molecule is non-polar due to its symmetrical structure, has a very low surface tension and has low cohesive and adhesive forces to other substances. Furthermore, other polyfluoroethylene, hexafluoropropene and/or polydimethylsiloxane would also be conceivable as hydrophobic coatings, with polydimethylsiloxane even having an advantageous antithrombogenic effect.

On the other hand, suitable hydrophilic polymers are coatings that can form hydrogen bonds, so that a film of water forms can be easily attached to the surface. Hydrophilic coatings can consist of only one hydrophilic polymer, or can comprise a combination of hydrophilic polymers. Advantageous conceivable hydrophilic coatings include hydrogels or also polyvinylpyrrolidone, the properties of which can be further adjusted by adding vinylpyrrolidone copolymers.

The stiffening portion of the hose assembly may form part or all of the hose assembly.

The length and the area of the stiffening section can advantageously be easily adapted to the respective problem. A length of the stiffening layer of around 30 cm up to the front end, or a complete stiffenability of the hose device, is particularly advantageous.

Thus, the stiffening section can only take up the area that is required to fix the hose device in one area. The remainder of the tubing assembly can benefit from the advantages of a lack of a stiffening layer, such as increased resiliency. This means that costs can also be reduced and full functionality can still be guaranteed.

The entire length of the hose device is preferably between 10 and 120 cm long, depending on the desired application, and the length of the stiffening section can extend over the entire length or a section.

The inner tube of the tube device can have an inside diameter of 1 to 11.33 mm.

A small outer diameter is very important for minimally invasive procedures. Nevertheless, a certain minimum inner diameter is necessary for the passage of wires, tools and/or stents. The inner diameter of catheters is given in French, with one French equaling 0.33 mm. Thus, the tubing device has an internal diameter of 3-32 Fr. So that a small internal diameter can be achieved, as a result of which tools and, for example, stents can be inserted, and the rigidity of the tube device is ensured, the layers of the tube device must also be produced with very thin walls. A small inner diameter is necessary in order to find space in narrow vessels or to be able to make turns of up to around 180° with the hose device in vessels. It is therefore a particularly advantageous feature of the invention that the hose device is fully functional even with a small internal diameter and can be manufactured at very low cost. The outside diameter is preferably at most 4 Fr, in particular at most 2 Fr, larger than the inside diameter. With an inner diameter of 6 Fr, the outer diameter is at most 10 Fr, so that the tube device is very compact and can be guided more easily around branches of vessels.

The inner tube of the tube device can preferably have at least two lumens, so that several devices can be inserted through the tube device in separate lumens.

Several separate lumens in a hose device can be advantageous so that snagging or jamming cannot occur so easily when tools and/or devices are used at the same time. This offers the advantage that multiple functions, such as guiding the guide wire and inserting, and/or preparing tools and/or devices, can be performed simultaneously. In addition, a shaped wire can thus be used in parallel with a guide wire in one lumen in each case. However, an additional soft dilator is preferably used.

The set includes at least one tube device as described above and a dilator, in particular at least one soft dilator and a shaped wire and/or guide wire.
This ensures the full range of functions and all components are compatible.

The wire can be a guide wire and/or a shaping wire.

The guide wire and the shaped wire can be inserted into the inner tube. In particular, the shaped wire has bends for guiding the hose device and/or is designed to be deformable into bends. Preferably, a bend of the forming wire can be adjusted so that the forming wire can be used flexibly, as is known in the art.

A shaped wire is in particular rotationally stable and/or torsionally stable in order to guide the dilator tip.

The forming wire and/or the lumen into which it is inserted is preferably coated, treated or formed of a very low friction material to facilitate insertion and exit of the forming wire.

Common shapes for shaping wire include straight wire, hockey stick, cobra, SOS, and Berenstein. The forming wire may have one or two formed ends.

In addition, the set preferably includes at least one dilator. In particular, the dilator is designed to be easily deformable and is therefore a soft dilator.

The shaping wire serves to control the flexible front area of the tube device and/or the dilator as a shaping device in the vessels. For this purpose, the shaped wire is preferably bent depending on the intended use and can be inserted into the hose device. The bend in the shaped wire is preferably very flexible, so that during insertion the shaped wire only bends at the end of the tube device and/or on the dilator, since the rigidity of the shaped wire is only sufficient at the end of the tube device and/or on the dilator to bend it . Preferably, the tube device cannot be bent by the forming wire, but only the soft dilator. The bend can thus be completed by the shaped wire and the tube device can then be inserted further into the desired vessel or stiffened.

The soft dilator is preferably longer than the respective hose device, in particular at least 15 cm longer.

The soft dilator can be soft over its entire length, or only at the tip of the soft dilator.

When the soft dilator is fixed with the longitudinal axis horizontal, so that the foremost 5 cm to the tapered tip of the dilator are free and a 30g weight orthogonally exerts force at the tip of the dilator, the tip of the soft dilator will deflect over a range of 30mm to 48mm, specifically 42mm. In comparison, the tip of a hard dilator only deflects 23 mm. Compared to a hard dilator, the deflection of a soft dilator is essentially at least 25% greater with the same shape of the dilators.
The tapering of the soft dilator is 20 to 80 mm, in particular 40 mm, long from the tip, at the opening for the guide wire, to the expansion to the inner diameter of the tube device.

The soft dilator may have two lumens, a lumen for the guide wire and a lumen for the forming wire. The lumen for the shaping wire is closed in the tip of the dilator, the lumen for the guide wire is open.

A closed lumen for the shaping wire has the advantage that the shaping wire can only be used to create the shape and cannot injure the vessels. In addition, the shaped wire is preferably flattened rather than tapered, so that the interior of the lumen and the closed end cannot be damaged.

A further lumen also offers the advantage that a lumen for introducing substances can be used parallel to the formability of the dilator and/or the front hose device by the form wire. Thus, for example, a contrast medium can be introduced into the vessel without having to remove the shaped wire.

The inner diameter of a lumen of the dilator in relation to the use of a guide wire is preferably in a range of essentially 0.2 mm to 1.2 mm, in particular 0.35 mm to 0.97 mm.

The transition between the hose device and the dilator is preferably essentially form-fitting and the dilator preferably has an outside diameter of essentially 1 mm to 11.33 mm in this area.

The soft dilator can have a hydrophilic coating, likewise using the measures already set out above with regard to the hose device. The soft dilator is preferably softer than the shaping wire so that the dilator can be deformed by the shaping wire.

The soft dilator is preferably visible in X-rays, in particular due to the measures already set out with regard to the hose device.
In particular, at least the foremost 4 cm of the dilator should be located using x-ray techniques.

The soft dilator can also be used independently of the previously described tube device with previous tube devices.

The soft dilator can be made of silicone or thermoplastics.
The soft dilator can be identified by color coding from conventional hard dilators or dilators included in the set.

The hard dilator is inserted as the first part in front of the tube device after insertion of the guide wire into the vessel and temporarily widens the vessel for the insertion of the tube device. For this purpose, the dilator is conically shaped.

The set can also include a hard dilator. This allows the doctor to choose which dilator is better suited to the situation.

A method for treating a patient also leads to the solution of the object, wherein a hose device as described above is inserted into a vessel of a patient.

Such a method leads to safe and quick treatment of the patient.

The tubing assembly can be stiffened once the tubing assembly is positioned on a target vessel.

This enables safe access for the actual treatment of the target vessel.

As has also been customary up to now, access to an access vessel is preferably first created with a needle. A guide wire is inserted through this needle into the access vessel and the needle is then removed from the vessel. A dilator, in particular a hard dilator, is inserted into the access vessel via the access wire. The rigid dilator is thus preferably used and sold in conjunction with a tubing device and is well known in the art. A hard dilator is insertable into the tubing assembly to encircle the guidewire and the space between the guidewires and hose device occupies. The hard dilator is very stiff and can therefore be used to expand the vessel wall when entering the vascular system.

When the hard dilator is fixed with the long axis horizontal so that the foremost 5 cm is exposed to the tapered tip of the dilator, and a 30 g weight at the tip of the dilator applies orthogonal force, the tip of the hard dilator deflects a range of 10 up to 35 mm, in particular 23 mm.
The tapering of the hard dilator is 20 to 80 mm, in particular 40 mm, long from the tip at the opening for the guide wire to the expansion to the inner diameter of the tube device.

The hard dilator can be exchanged for a soft dilator, preferably afterwards. The soft dilator can then be advanced to in front of the target vessel. The guide wire can then be advanced into the target vessel. The guide wire and the shaped wire are then fixed and the dilator with the tube device is advanced into the target vessel and fixed. The tube device is then advanced into the target vessel, also in a flexible state, and stiffened.

After the tubing device has stiffened, the soft dilator is pulled out with the forming wire.

The desired intervention in the target vessel can then begin.

This results in the advantage that a soft dilator can be used simultaneously as an optimized guide device and diagnostically. This saves additional time and the procedure can be carried out technically more easily without changing the material.

The object is further achieved by a method for selectively stiffening a hose device.

The tube device is stiffened by introducing a fluid into the space between the inner tube and the stiffening layer.

The selective stiffening of the tube device enables on the one hand the required flexibility for insertion into the vessels and on the other hand the selective stability of a stiffened tube device or a stiffening section. Time in use is also minimized since a prior art tubing assembly can often be deflected from its place of use, for example by blood flow, tampering with the tubing assembly, or slippage of the tubing assembly.
In addition, on the one hand, for safety reasons, a fluid should be selected in such a way that no damage to health can occur even in the event of severe damage to the hose device. In this context, a device for monitoring the pressure from the introduced fluid would also be conceivable.

The hose device can become flexible again by reducing the pressure in the space between the inner hose and the stiffening layer. Preferably, the tubing is in the elastic state when reduced to substantially atmospheric pressure and pressure in the blood vessels of a human. It is particularly important that this method can be activated and deactivated selectively. The hose device can thus be introduced flexibly. At the target site, the tube device for the minimally invasive surgical procedure can be stiffened according to the individual anatomy and then made elastic again for removal in order to avoid possible damage to health. Possible damage, such as strokes, can be caused by the loosening of deposits or thrombi, as well as tools and/or devices and/or small parts that have been introduced. These risks are minimized and more precise work is made possible by an at least partially stiffened hose device.

It is therefore of particular importance to avoid this potential damage and a major advantage of the invention is that the hose device can be selectively stiffened as required by introducing a fluid into the space between the inner hose and the stiffening layer.

It is also advantageous that the pressure only needs to be built up in order to stiffen the hose device and reduced in order to make it elastic, since this ensures that the hose device can be released again even if the pressure device fails. If pressure had to be built up to make them elastic, in the case of a leaky tubing device, there would be a stiffened tubing device in a person's vessels. This could not be removed, or only with great difficulty, and/or at great risk to humans.

Figur 1:

einen Versteifungsabschnitt der Schlauchvorrichtung,

Figur 2:

ein Ausführungsbeispiel des Versteifungsabschnitts,

Figur 3:

ein Ausführungsbeispiel des Versteifungsabschnitts,

Figur 4:

ein Ausführungsbeispiel des Versteifungsabschnitts,

Figur 5:

ein Ausführungsbeispiel des Versteifungsabschnitts,

Figur 6:

eine Struktur der Versteifungsschicht,

Figur 7:

eine alternative Struktur der Versteifungsschicht,

Figur 8:

einen Querschnitt des Versteifungsabschnitts der Schlauchvorrichtung,

Figur 9:

ein Querschnitt des Versteifungsabschnitts mit eingeführtem Dilatator mit einem Lumen,

Figur 10:

einen Querschnitt des Versteifungsabschnitts mit eingeführtem Dilatator mit zwei Lumina,

Figur 11:

eine Schlauchvorrichtung mit Versteifungsabschnitt,

Figur 12:

ein Set einer Schlauchvorrichtung mit Dilatator und zusätzlichem Führungsdraht,

Figur 13:

ein Dilatator mit einem eingeführten Führungsdraht,

Figur 14:

ein Dilatator mit einem eingeführten Führungsdraht und Formdraht,

Figur 15:

ein Set einer Schlauchvorrichtung mit Dilatator und zusätzlichem Führungsdraht mit partiell entfernten Schichten,

Figur 16:

ein Längsschnitt eines Dilatators in einer Schlauchvorrichtung mit zwei Lumina.

In the following, embodiments of the invention are described in detail with reference symbols. Here shows

Figure 1:

a stiffening section of the hose device,

Figure 2:

an embodiment of the stiffening section,

Figure 3:

an embodiment of the stiffening section,

Figure 4:

an embodiment of the stiffening section,

Figure 5:

an embodiment of the stiffening section,

Figure 6:

a structure of the stiffening layer,

Figure 7:

an alternative structure of the stiffening layer,

Figure 8:

a cross section of the stiffening section of the hose device,

Figure 9:

a cross section of the stiffening section with inserted dilator with a lumen,

Figure 10:

a cross-section of the stiffening section with inserted dilator with two lumens,

Figure 11:

a hose device with stiffening section,

Figure 12:

a set of tubing device with dilator and additional guide wire,

Figure 13:

a dilator with a guide wire inserted,

Figure 14:

a dilator with an inserted guide wire and shaping wire,

Figure 15:

a set of a tube device with dilator and additional guide wire with partially removed layers,

Figure 16:

Figure 12 shows a longitudinal section of a dilator in a dual lumen tubing device.

Identical reference numbers in the figure indicate identical components.

figure 1 FIG. 12 shows a stiffening section 101 of the tube device 100 of a preferred embodiment of the invention with four layers of tube. The tubing assembly 100 is shown in open portions of each layer for clarity. From outside to inside is an outer tube 4, a stiffening layer 3, a pressure hose 2 and an inner hose 1 are arranged.
For stiffening, the pressure tube 2 is filled with an isotonic sodium chloride solution at a pressure of 16 bar and the stiffening layer 3 thus presses against the outer tube 4 by being moved radially outwards. When the pressure is removed, the stiffening layer 3 is also moved radially inwards again and the stiffening of the stiffening section 101 decreases.

In this embodiment, the pressure hose 2 is made of thermoplastics and can thus be expanded and elastically radially deformed by the introduction of a saline solution.

The stiffening layer 3 can also be moved radially inward again when the applied pressure is removed. This ensures that the hose device 100 can always be removed, particularly when the pressure can no longer be built up. In the basic state, the tube device 100 is designed to be movable without pressure, so that there is no risk of irreversible stiffening of the tube device 100 in the event of a defect. In this case, the stiffening layer 3 is formed from a loose mesh made of high-grade steel and/or plastic that can be moved in relation to one another and runs in the longitudinal direction to form a partial vector. In this way, the stiffening layer 3 can expand easily and a high level of friction with the outer tube can be produced.

In this exemplary embodiment, the outer hose 4 and the inner hose 1 comprise polysiloxanes and a stainless steel spiral, the stainless steel spiral being helically aligned along the longitudinal axis of the hose device 100 and embedded in the polysiloxane is and is completely enclosed. In this context, however, the alternative use of polyurethane for the inner 1 and outer tube 4 would also be conceivable. The inside of the inner tube 1 is coated with polytetrafluoroethylene, so that the lowest possible frictional resistance occurs within the inner tube for devices, tools, liquids and small parts that are introduced. The outer tube 4 is also hydrophilic due to a coating 5 with polyvinylpyrrolidone. Thus, insertion into a body passage is easier and can be carried out atraumatically. In addition, the sliding properties of the tube device 100 within the vessels are increased by the coating 5 .

Figures 2-5 show explicit embodiments as an alternative to FIG figure 1 referred.

figure 2 shows the stiffening section 101 of the hose device 100, which shows a stiffening layer 3 with a mesh made of stainless steel, the individual stabilizing elements 18 of the stiffening layer 3 being manufactured to be displaceable and/or sliding relative to one another. The stiffening layer 3 can be moved radially outwards by the pressure hose 2 without strong resistance and can stiffen the stiffening section 101 by friction with the outer hose 4 .
However, other materials for the stabilizing elements 18, such as polyamide, are also conceivable.

figure 3 shows an exemplary embodiment of the stiffening section 101 of the tube device 100 analogously to FIG figure 2 . In addition to the mesh made of stainless steel of the stiffening layer 3 with stabilizing elements 18, the reinforcement 19 made of stainless steel of the inner and outer hose 1, 4 was shown.
The reinforcement 19 is designed as concentrically as possible around the longitudinal axis of the hose device 100, so that the hose device 100 continues to be designed as flexibly as possible to the sides when it is not in the stiffened state. In this exemplary embodiment, the reinforcement 19 is realized by rings, but a spiral-shaped reinforcement 19 and a mesh-shaped reinforcement 19 are also conceivable.

figure 4 shows an embodiment of the stiffening section 101 of the hose device 100, wherein the pressure hose 2 can press radially outwards against the outer hose 4 by unfolding a folded structure 20, the stiffening layer 3 and stabilizing elements 18. Thus, the expansion of the pressure hose 2 does not change even after repeated use, since no or essentially no elastic deformation takes place. The pleated structure 20 of the pressure tube 2 unfolds when pressure is applied with the pressure tube 2 by the introduction of the saline solution and folds back when the pressure is removed. This also has the advantage that the elastic hysteresis due to the folded structure 20 is minimized. Thus, it is minimized that deformation remains after removal of the deflecting force. The safety and the durability of the pressure hose 2 of the hose device 100 are thus guaranteed.

figure 5 12 shows an exemplary embodiment of the stiffening section 101 of the tube device 100, the stiffening layer 3 forming a tight tube as a unit with a plastic and the stabilizing elements 18. FIG. The stiffening layer 3 can thus additionally assume the function of the pressure hose 2 and, by means of an applied pressure, radially outwards be pressed against the outer tube 4 in order to stiffen the stiffening section 101 .

figure 6 shows an embodiment of the stiffening layer 3 with stabilizing elements 18, wherein the mesh formed is not rigidly connected to one another at the interfaces, but is designed to be freely movable relative to one another in order to ensure radial deformability. In this exemplary embodiment, the stabilizing elements 18 are formed at an angle of essentially 30° to the longitudinal axis of the hose device 100 .

figure 7 shows another embodiment of the stiffening layer 3 with stabilization elements 18 analogous to figure 6 , wherein additional longitudinal stabilizing elements 21 are shown essentially parallel to the longitudinal axis, which additionally increase the friction when they are pressed radially against the outer hose 4.

figure 8 FIG. 12 shows a cross-section of the stiffening section 101 of the tube device 100 with four layers of tube. An outer hose 4, a stiffening layer 3, a pressure hose 2 and an inner hose 1 can be seen from the outside inwards. In addition, the area A between the inner hose and the outer hose 4, between which the pressure can be built up, was marked. The pressure applied between the inner hose 1 and the pressure hose 2 allows the stiffening layer 3 to move outwards radially through the pressure hose 2, which presses the stiffening layer 3 onto the outer hose 4 and thus stiffens it. The choice of materials and functionality is otherwise analogous to figure 1 .

figure 9 shows the cross section of the stiffening section 101 with the four tube layers 1, 2, 3, 4 analogous to figure 8 . Additionally points figure 9 an inserted soft dilator 300, which has a lumen 15 for the guide wire 12 and for introducing and removing substances and/or tools from/to the vessels. In the region A between the inner and outer tube 1, 4, a radial displacement of the pressure tube 2 and the stiffening layer 3 for stiffening the stiffening section 101 can take place due to pressure. During the stiffening process, the pressure in the space between the inner hose 1 and the pressure hose 2 is increased to such an extent that the pressure hose 2 moves radially and the stiffening layer 3 presses against the outer hose 4 .

figure 10 shows the cross section of the stiffening section 101 analogous to figure 9 , wherein the inserted soft dilator 300 has the lumen 15 for the guide wire 12 and a lumen 16 for the forming wire 14. The lumen 15 for the guidewire 12 is still centrally located in the soft dilator 300, while the lumen 16 of the forming wire 14 is offset to one side. Guidance through the vessels with the guide wire 12 is thus still ensured by the radially symmetrical shape, with the shaped wire 14 being able to additionally adapt the shape of the soft dilator 300 .

figure 11 shows the tube device 100 with a stiffening section 101. The tube device 100 shows a conical front area 7, so that the tube device 101 can be used more easily and atraumatically for penetrating vessels. The fluid coupling 8 is used to supply fluid and to stiffen the stiffening section 101 of the hose device 100. A side connection 10 is also shown, which is used to supply liquids. A hemostasis valve 11 also prevents blood from escaping from the tubing device 100 can escape and still devices can be introduced. The outer tube 4 also has a hydrophilic coating 5 .

figure 12 shows the set 200 of a hose device 100 and a stiffening section 101 with a circumference that is preferably included at least in the set.
figure 12 FIG. 12 shows the guide wire 12 having a bent front end 13 for guiding the tube device 100. FIG. Furthermore, a conical, long tip 6 of a soft dilator 300, formed from very elastic polysiloxane, can be seen, which can be used as a guiding device. In addition, the front area 7 of the tube device 100 is conically designed so that the tube device 100 can be inserted more easily and preferably also more easily guided around windings in vessels. This is additionally facilitated by a hydrophilic coating 5 on the outer tube 4.
Furthermore, a fluid coupling 8 in figure 12 to see, which allows the delivery of a fluid, preferably a saline solution.
In figure 12 the guide element 9 of the soft dilator 300, which can be used for the control and translation of the tip of the dilator 6, can also be seen. A side connection 10 also enables liquids to be supplied, such as a contrast solution, and at the same time closes the tube device 100.

In addition, the tubing device 100 of the set has a haemostatic valve 11 which closes the set 200 and allows devices, tools and/or small parts to be inserted, but prevents blood from escaping. In this embodiment, the hose assembly 100 and the soft Dilator 300 iron dust so that the movements can be visualized by x-ray methods.

figure 13 12 shows the soft dilator 300 with a guide wire 12 inserted. The tip of the dilator 6 is tapered for easy maneuvering and insertion. It should be noted here that the guide wire 12 can be moved independently of the soft dilator 300 and can thus specify the path into a vessel. In this context, the guide element 9 of the soft dilator 300 can be used to move the soft dilator 300 in the longitudinal direction. The soft dilator 300 can thus be slid along the predetermined direction of the guide wire 12 .

figure 14 shows the soft dilator 300 with inserted guide wire 12 and inserted shaped wire 14. The shaped wire 14 is shown in accordance with FIG figure 10 laterally inserted into a second separated lumen 16, so that the lumen 15 of the guide wire 12 can still be arranged centrally in the dilator 6. The tip of the dilator 6 can be controlled in the vessels with the aid of the guide element 9 according to the specified bends 13 of the guide wire 12 and dilator deformation 17 by the shaped wire 14 and can be moved and/or stiffened along the directions specified by the wires 12, 14.

figure 15 shows the set 200 of the hose device 100 with a stiffening section 101 analogously to FIG figure 12 , where analogous designations have not been repeated. The outer hose 4 has been partially removed for a better view, so that the stiffening layer 3 and stabilizing elements 18 and the pressure hose 2 underneath can be seen. In addition, a section B of the stiffening section 101 is additionally removed Stiffening layer 3 and pressure tube 2 shown so that the guide wire 12 in the lumen 15 of the soft dilator 300 is visible.

figure 16 shows a soft dilator 300 with a lumen 15 for the guide wire 12 and a lumen 16 for the shaped wire 14. The additional layers of a tube device 100 according to the invention with a stiffening section 101 have been omitted in this longitudinal section to better illustrate the exemplary embodiment.
The longitudinal section shows that the tip of the dilator 6, which protrudes from the conical front area 7 of the hose device 100. The tip of the dilator 6 is shaped into a dilator deformation 17 by the shaping wire 14 . The shaping wire 14 cannot exert enough force to shape the tube device during insertion and removal, but the deformation into a dilator deformation 17 only occurs at the tip of the dilator 6 . In addition, shows figure 16 1 shows that the lumen 16 for the shaping wire 14 has a closed end 22. Thus, the shaping wire 14 can impose a dilator deformation 17, which is also present if the guide wire 12 has to be removed. Furthermore, due to the dilator deformation 17 of the shaped wire 14 in combination with the predetermined bend 13 of the guide wire 12, a practicable guidance of the tube device 101 in vessels can be ensured.

Claims (16)

Tube device (100), in particular a sluice device for insertion into a body passage, comprising a stiffening section (101) comprising an inner tube (1), a stiffening layer (3) and an outer tube (4), the stiffening layer (3) being concentrically outside the inner tube (1st ) is arranged and the outer hose (4) is arranged concentrically outside the stiffening layer (3), the inner hose (1) and the outer hose (4) being radially stiff and the stiffening layer (3) being radially movable, characterized in that in that a pressure can be built up between the inner tube (1) and the stiffening layer (3) such that the stiffening layer (3) can be pressed from the inside against the outer tube (4) and thus stiffens the stiffening section (101) under pressure. Hose device (100) according to Claim 1, characterized in that an expandable, in particular elastic and/or unfoldable, pressure hose (2) is arranged between the inner hose (1) and the stiffening layer (3). Hose device (100) according to one of the preceding claims, characterized in that the stiffening layer (3) comprises at least two stabilizing elements (18), the orientation of the stabilizing elements (18) having at least one partial vector in the longitudinal direction of the hose device and the stabilizing elements (18) preferably can be moved against each other. Hose device (100) according to Claim 3, characterized in that the stabilizing elements (18) are made of metal and/or plastic and in particular a large number of stabilizing elements (18) are woven into a mesh. Hose device (100) according to one of the preceding claims, characterized in that the inner hose (1) and the outer hose (4) are pressure-tight and are in particular made of a plastic and/or metal. Hose device (100) according to one of the preceding claims, characterized in that the hose device (100) comprises a fluid coupling (8) through which a fluid can flow into the area between the inner hose (1) and the stiffening layer (3), in particular into the pressure hose (2nd ), is collectible. Tubing device (100) according to one of the preceding claims, characterized in that the tubing device (100) at least partially comprises a material visible in X-rays, in particular metal. Hose device (100) according to one of the preceding claims, characterized in that a front region (7) of the hose device (100) is conical. Hose device (100) according to one of the preceding claims, characterized in that a hydrophilic or hydrophobic coating (5) is arranged on the outside of the outer hose (4). Hose device (100) according to any one of the preceding claims, characterized in that the stiffening section (101) forms part or all of the hose assembly (100). Hose device (100) according to one of the preceding claims , characterized in that the inner hose (1) has an inner diameter of 1 to 11.333 mm. Tubing device (100) according to one of the preceding claims , characterized in that the inner tube (1) of the tubing device (100) has at least two lumens, so that several devices can be introduced through the tubing device (100) in separate lumens. Set comprising a hose device (100) according to one of the preceding claims and at least one dilator, and in particular at least one soft dilator (300) and a shaped wire (14) and/or guide wire (12). Method for selectively stiffening a tube device (100) according to one of the preceding claims, characterized in that the tube device (100) is stiffened by introducing a fluid into the space between the inner tube (1) and the stiffening layer (3). Method according to Claim 11, characterized in that the hose device (100) becomes mobile again by reducing the pressure in the space between the inner hose (1) and the stiffening layer (3). A soft dilator comprising two lumens, a lumen (15) for the guide wire (12) and a lumen (16) is provided for the forming wire (14), characterized in that the lumen (16) for the forming wire (14) in the tip of the dilator (6) is closed and the lumen (15) for the guide wire (12) is open, wherein the soft dilator (300) preferably has a hydrophilic coating, the soft dilator (300) is preferably softer than the forming wire (14), and the soft dilator (6) is preferably X-ray visible.

Images